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Ottawa Marriott Hotel

17 oct 2017 7:00 a.m. - 18 oct 2017 3:00 p.m.

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

DIA Annual Canadian Meeting

Session 3B: Biosimilars: Evolving Perspectives

Session Chair(s)

Loretta  Del Bosco

Loretta Del Bosco

Director, Regulatory Affairs Quality Assurance Operations, AbbVie Corporation, Canada

Gain an overview from two key North American Regulators from Health Canada and FDA, as well as from the Alliance for Safe Biologic Medicines on the exciting and evolving landscape of Biosimilars. Being at the forefront of the biosimilar discussion is key to the future of our health care system in Canada, and abroad. This session will highlight key concepts and challenges.

Speaker(s)

Leah  Christl, PHD

Leah Christl, PHD

Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy, Amgen, United States

FDA Update: The Development and Approval of Biosimilar Products in the US

Harry  Gewanter

Harry Gewanter

Immediate Past Chair, Alliance for Safe Biologic Medicines, United States

Understanding Canadian Prescriber Perspectives on Key Considerations for Biologics and Biosimilars

Stephanie  Hardy, MPH, RAC

Stephanie Hardy, MPH, RAC

OPIC, Biologics and Genetic Therapies Directorate, HPFB, Health Canada, Canada

Biosimilars: An Update on Health Canada Activities

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